Allergan announced yesterday that the United States Food and Drug Administration (FDA) has approved OZURDEX™ (dexamethasone intravitreal implant) 0.7 mg as the first drug therapy indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Retinal vein occlusion (RVO), including BRVO and CRVO, is the second most common retinal vascular disease after diabetic retinopathy and is a significant cause of vision loss.

OZURDEX™ is administered via intravitreal injection delivering dexamethasone, a highly potent corticosteroid, via Allergan’s proprietary NOVADUR™ solid polymer delivery system. Via the NOVADUR™ delivery system, OZURDEX™, a biodegradable implant which enables the extended release and effect of dexamethasone, is placed in the vitreous cavity in the back of the eye treating the macular edema associated with RVO, thereby improving a patient’s visual acuity.

With OZURDEX™, patients can achieve high concentrations of dexamethasone to reduce macular edema associated with RVO, while relying on the delivery of a consistent low level of dexamethasone to maintain edema control and enhance safety.

The announcement this week of the FDA’s approval for Ozurdex is outstanding! This is a novel drug delivery system that has been patiently percolating in R & D for about 15 years.

Ozurdex is unique. It is similar to intravitreal injection and is given as such, but has sustained released characteristics due to a unique drug delivery system. Unlike other delivery systems, the polymer drug delivery “Novadur” system, once rid of its product, biodegrades.

I believe the timing of this release is great news for retinal specialists. The FDA has approved this for branch and central vein occlusions, but there will be more “off-label” indications soon to be reported.